The invention relates to implantable articles and methods for manufacturing such articles. More particularly, the invention relates to bone prosthesis and processes for manufacturing the same.
There are known to exist many designs for and methods for manufacturing implantable articles, such as bone prosthesis. Such bone prosthesis include components of artificial joints, such as elbows, hips, knees, and shoulders. An important consideration in the design and manufacture of virtually any implantable bone prosthesis is that the prosthesis has adequate fixation when implanted within the body.
Early designs of implantable articles relied upon the use of cements such as polymethylmethacrylate to anchor the implant. The use of such cements can have some advantages, such as providing a fixation that does not develop freeplay or does not lead to erosion of the joining bone faces postoperatively. However, the current trend is to use these cements to a lesser extent because of their tendency to lose adhesive properties over time and the possibility that the cement contributes to wear debris within a joint.
Recently, implantable bone prosthesis have been designed such that they encourage the growth of hard tissue (i.e., bone) around the implant. The bone attachment usually occurs and growth is promoted when the surface of the implantable bone prosthesis is irregular or textured. The interaction of newly formed hard tissue in and around the textured surface of the implantable bone prosthesis has been found to provide a good fixation of the prosthesis within the body. A greater degree of bone fixation can usually be achieved where bone-engaging surfaces of an implantable bone prosthesis are more porous or irregular.
Porous or irregular surfaces can be provided in implantable articles by a variety of techniques. In some instance, an irregular surface pattern or surface porosity is formed in an implantable bone prosthesis by embossing, chemical etching, milling or machining.
Another problem which has been observed in the use of known hip joint systems relates to the proper distribution of stresses within the prosthesis and throughout the surrounding bone. If too little stress is applied to the bone, resorption can occur leading to atrophy of the affected area. Too much stress may also lead to resorption and atrophy, or may result in an undesirable hypertrophy of the affected area. In some prior art, femoral stem designs excessive forces are transmitted through the relatively rigid stem to the distal portion, resulting in hypertrophy of the bone surrounding the distal portion, and atrophy of the bone surrounding the proximal portion of the stem. Accordingly, there exists a need for an improved hip joint prosthesis which addresses these needs and other problems of prior hip joint designs.
Attempts have been made to provide for proximal loading of the prosthesis within the bone. For example, in U.S. Pat. No. 5,004,075 to Vermeire a series of parallel spaced apart linear grooves 28 were positioned perpendicular to the longitudinal axis 22 of the neck of the prosthesis. A second set of parallel spaced apart linear grooves 29 were positioned generally perpendicular to the grooves 28. These grooves serve to provide support in the proximal region of the stem of this prosthesis.
U.S. Pat. No. 4,865,608 to Brooker, Jr. a series of spaced apart parallel grooves 24 and 24′ were positioned along the outer periphery of the opposite sides of the proximal portion of the stem. The grooves were positioned at an angle of approximately 70 degrees with respect to the longitudinal axis of the stem.
In total hip arthroplasty, initial and long term success are achieved through the use of a device which is designed to provide at least two features. The first of these features is the stable initial or immediate postoperative fixation within the femur. The second feature is the means to provide an optimal environment for a long-term stability in the femur. In the past, fixation has been achieved through the use of bone cement, porous coatings and bio-ceramics. Bio-ceramics includes such compositions as hydroxyapatite and tricalcium phosphates. Many of these cements, coatings and bio-ceramics have provided good clinical outcomes, however, none have addressed the biomechanics of load transmission through the proximal femur.
Methods of achieving femoral fixation in the prior art have met with some success. These methods include simple press fit, surface roughness, porous coating, and bio-ceramics. Many devices have included texturing to transfer load in favorable mechanical modes. However, none of the prior art devices have designed the texturing (steps) to transfer load along the natural load paths of the proximal femur. The Brooker patent has angled steps on the anterior and posterior face, however, on the medial edge, the steps are longitudinal. This design will not appropriately transmit load to the medial calcar. The Vermeire patent has no steps on the medial edge, posing a similar problem.
A commercially available product from Stryker Howmedica Osteonics known as the Omni Fit Femoral Stem has normalization features which transmit load directly vertical. This load path is not natural. This device has no medial steps. A commercially available product from DePuy Orthopaedics, Inc., the JMP S-ROM transmits axial loads, but again, does not follow the natural load path.